EP2036574A1 - Préparation médicamenteuse destinée au traitement péroral de l'excès pondéral, du diabète sucré et de maladies accompagnées d'une perturbation de la tolérance du glucose - Google Patents

Préparation médicamenteuse destinée au traitement péroral de l'excès pondéral, du diabète sucré et de maladies accompagnées d'une perturbation de la tolérance du glucose Download PDF

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Publication number
EP2036574A1
EP2036574A1 EP07794025A EP07794025A EP2036574A1 EP 2036574 A1 EP2036574 A1 EP 2036574A1 EP 07794025 A EP07794025 A EP 07794025A EP 07794025 A EP07794025 A EP 07794025A EP 2036574 A1 EP2036574 A1 EP 2036574A1
Authority
EP
European Patent Office
Prior art keywords
antibodies
subunit
beta
insulin receptor
dilution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP07794025A
Other languages
German (de)
English (en)
Other versions
EP2036574A4 (fr
Inventor
Oleg Iliich Epshtein
Svetlana Alexandrovna Sergeeva
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from RU2006119655/15A external-priority patent/RU2438707C2/ru
Priority claimed from RU2006119658/15A external-priority patent/RU2437678C2/ru
Application filed by Individual filed Critical Individual
Priority to EP11007331A priority Critical patent/EP2395021A1/fr
Publication of EP2036574A1 publication Critical patent/EP2036574A1/fr
Publication of EP2036574A4 publication Critical patent/EP2036574A4/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0004—Homeopathy; Vitalisation; Resonance; Dynamisation, e.g. esoteric applications; Oxygenation of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies

Definitions

  • the invention concerns the field of medicine and may be used for effective treatment and prevention of obesity, diabetes mellitus and other diseases associated with impaired glucose tolerance.
  • a method of obtaining solid oral form of the drug including pressing of dry ground components containing the active substance and pharmaceutically acceptable additives ( RU 2203054 C2 , A61 K9/20, 2003) is also known.
  • the invention is intended for development of an effective antibody-based drug used for peroral treatment of obesity, diabetes mellitus and other diseases associated with impaired glucose tolerance with no side effects and the method of its production in solid dosage form.
  • a peroral drug for the treatment of diabetes mellitus and other diseases associated with impaired glucose tolerance contains antibodies to beta-subunit of the insulin receptor in activated form obtained by multiple successive dilution and external action in accordance with homeopathic technology.
  • the medicinal drug contains monoclonal, polyclonal, recombinant, immune or natural antibodies to beta-subunit of the insulin receptor in activated form.
  • the medicinal drug contains mixture of various homeopathic dilutions of antibodies to beta-subunit of the insulin receptor in activated form.
  • method of production of solid oral form for the treatment of diabetes mellitus and other diseases associated with impaired glucose tolerance includes mixing of effective amount of carrier irrigated in a fluidized bed by combination of aqueous-alcohol dilution of antibodies to beta-subunit of the insulin receptor in activated form obtained by combining multiple successive dilution-reduction in antibody concentration and external action according to homeopathic technology and dried at temperature not exceeding 35°C, with pharmaceutically acceptable additives and subsequent pelletization of mixture by direct dry pressing.
  • Lactose with particle size of 150-250 ⁇ m is used as a carrier for this method of obtaining solid medicinal form.
  • the medicinal drug prepared in accordance with the invention is a novel antibody-based pharmaceutical drug characterized by specific pharmacological activity, high efficacy; absence of side effects, ecological purity and low cost.
  • the medicinal drug is prepared in the following way.
  • Isolated antibodies are subjected to successive and multiple dilution-reducing their concentration and subjecting them to external, usually mechanical treatment e.g. according to homeopathic technology of potentiating (see Homeopathic medicinal drugs. Guidelines on description and manufacturing. V. Shvabe, Moscow, 1967, pp. 12-38 ; or G. Keller, Homeopathy, Moscow, Medicina, 2000, part 1, pp. 37-40 ).
  • Ultrasound, electromagnetic or other physical influence can be used for external treatment in the process of concentration reduction.
  • the obtained dilution in the form of aqueous or alcohol solution may be used as a liquid dosage form for peroral administration into the body (in the form of drops) or for subsequent preparation of solid oral form.
  • Obtained dry homogeneous mixture is supplied to the pelletizing machine, for example, tablet-press Korsch - XL 400, to form round 150 - 500 mg tablets using direct dry pressing.
  • Patient D. 43 years old, underwent a course of obesity treatment. Complained of ineffective dietary treatment.
  • Antidiabetic activity of aqueous solution of the drug containing activated form of rabbit polyclonal antibodies to beta-subunit of the insulin receptor was studied in the model of outbred male rats with streptozotocin-induced diabetes.
  • the drug was administered intragastrically at a dose of 2.5 mL/kg per rat for 50 days.
  • Insulin Actrapid HM at 12 units/kg/day subcutaneously
  • glibenclamide MP Biomedical at a dose of 8 mg/kg/day per os
  • Patient S., 53 years old, BMI 30, has been suffering from insulin-independent diabetes mellitus for 8 years, the syndrome of diabetic foot is present.
  • the great toe of the right leg was amputated one year ago.
  • the patient complained of non-healing (1.5 months) ulcers on the right leg in the area of amputated toe.
  • the patient was assigned with rabbit polyclonal antibodies to beta-subunit of human insulin receptor (mixture of homeopathic dilution D6+C30+C50) at a dose of 1 tablet once daily (the tablet has to be dissolved in the mouth).
  • Three weeks later healing of ulcerative process was registered, and insulin tolerance was reduced.
  • the patient went on taking the drug for 3 months that resulted in stabilization of glycemia.
  • the patient noted significant body weight loss (IMT reduced to 28).

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Obesity (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Neurology (AREA)
  • Biochemistry (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Emergency Medicine (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
EP07794025A 2006-06-06 2007-05-31 Préparation médicamenteuse destinée au traitement péroral de l'excès pondéral, du diabète sucré et de maladies accompagnées d'une perturbation de la tolérance du glucose Withdrawn EP2036574A4 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP11007331A EP2395021A1 (fr) 2006-06-06 2007-05-31 Préparation médicamenteuse destinée au traitement péroral de l'excès pondéral, du diabète sucré et de maladies accompagnées d'une perturbation de la tolérance du glucose

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
RU2006119655/15A RU2438707C2 (ru) 2006-06-06 2006-06-06 Лекарственное средство для перорального лечения сахарного диабета и других заболеваний, сопровождающихся нарушением толерантности к глюкозе, и способ получения твердой лекарственной формы для пероральной терапии сахарного диабета и других заболеваний, сопровождающихся нарушением толерантности к глюкозе
RU2006119658/15A RU2437678C2 (ru) 2006-06-06 2006-06-06 Лекарственное средство для перорального лечения ожирения и способ получения твердой лекарственной формы для пероральной терапии ожирения
PCT/RU2007/000288 WO2007149010A1 (fr) 2006-06-06 2007-05-31 Préparation médicamenteuse destinée au traitement peroral de l'excès pondéral, du diabète sucré et de maladies accompagnées d'une perturbation de la tolérance du glucose

Publications (2)

Publication Number Publication Date
EP2036574A1 true EP2036574A1 (fr) 2009-03-18
EP2036574A4 EP2036574A4 (fr) 2009-07-01

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Family Applications (2)

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EP07794025A Withdrawn EP2036574A4 (fr) 2006-06-06 2007-05-31 Préparation médicamenteuse destinée au traitement péroral de l'excès pondéral, du diabète sucré et de maladies accompagnées d'une perturbation de la tolérance du glucose
EP11007331A Withdrawn EP2395021A1 (fr) 2006-06-06 2007-05-31 Préparation médicamenteuse destinée au traitement péroral de l'excès pondéral, du diabète sucré et de maladies accompagnées d'une perturbation de la tolérance du glucose

Family Applications After (1)

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EP11007331A Withdrawn EP2395021A1 (fr) 2006-06-06 2007-05-31 Préparation médicamenteuse destinée au traitement péroral de l'excès pondéral, du diabète sucré et de maladies accompagnées d'une perturbation de la tolérance du glucose

Country Status (11)

Country Link
US (2) US9308259B2 (fr)
EP (2) EP2036574A4 (fr)
JP (1) JP5687425B2 (fr)
KR (1) KR20090024241A (fr)
AU (1) AU2007261782A1 (fr)
BR (1) BRPI0712540A2 (fr)
CA (1) CA2654408C (fr)
EA (1) EA200802440A1 (fr)
IL (2) IL195755A (fr)
MX (1) MX2008015621A (fr)
WO (1) WO2007149010A1 (fr)

Cited By (9)

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WO2011038302A2 (fr) 2009-09-25 2011-03-31 Xoma Technology Ltd. Nouveaux modulateurs
WO2012010966A3 (fr) * 2010-07-21 2012-03-29 Oleg Iliich Epshtein Composition pharmaceutique combinée, et procédés de traitement du diabète et de troubles métaboliques
WO2012007845A3 (fr) * 2010-07-15 2012-03-29 Oleg Iliich Epshtein Procédé d'augmentation de l'effet d'une forme activée-potentialisée d'un anticorps
WO2012007847A3 (fr) * 2010-07-15 2012-04-12 Oleg Iliich Epshtein Compositions pharmaceutiques et méthodes de traitement
WO2012130872A1 (fr) * 2011-03-28 2012-10-04 Ablynx Nv Procédé de production de formulations solides comprenant des domaines variables uniques d'immunoglobuline
WO2015189711A3 (fr) * 2014-06-06 2016-02-18 Oleg Iliich Epshtein Composition à usage vétérinaire et procédé permettant d'améliorer la vie d'animaux, favoriser la prise de poids chez des mammifères et des oiseaux, augmenter l'efficacité de l'immunisation et prévenir et/ou traiter les maladies infectieuses (variants)
RU2610438C2 (ru) * 2011-06-02 2017-02-10 Общество С Ограниченной Ответственностью "Научно-Производственная Фирма "Материа Медика Холдинг" Способ лечения патологического синдрома и лекарственное средство центрального и периферического действия для лечения патологического синдрома
US9885711B2 (en) 2009-09-25 2018-02-06 Xoma Technology Ltd. Screening methods
US10253101B2 (en) 2015-08-06 2019-04-09 Xoma (Us) Llc Antibody fragments against the insulin receptor and uses thereof to treat hypoglycemia

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RU2181297C2 (ru) * 2000-06-20 2002-04-20 Эпштейн Олег Ильич Способ лечения патологического синдрома и лекарственное средство
RU2309732C1 (ru) 2006-03-13 2007-11-10 Олег Ильич Эпштейн Спрессованная твердая оральная форма лекарственного препарата и способ получения твердой оральной формы лекарственного препарата
EA200802440A1 (ru) 2006-06-06 2009-06-30 Олег Ильич ЭПШТЕЙН Лекарственное средство для лечения ожирения, сахарного диабета и заболеваний с нарушением толерантности к глюкозе
JP5616428B2 (ja) 2009-04-07 2014-10-29 ロシュ グリクアート アクチェンゲゼルシャフト 三価の二重特異性抗体
US9676845B2 (en) 2009-06-16 2017-06-13 Hoffmann-La Roche, Inc. Bispecific antigen binding proteins
CA2804967A1 (fr) 2010-07-15 2012-02-09 Oleg Iliich Epshtein Composition pharmaceutique a combinaison et methodes de traitement de maladies ou etats associes a des maladies neurodegeneratives
NZ606775A (en) * 2010-07-15 2015-08-28 Oleg Iliich Epshtein Combination pharmaceutical composition and methods of treating genitourinary system disorders
MX2013000807A (es) 2010-07-21 2013-10-28 Oleg Iliich Epshtein Un metodo para el tratamiento del trastorno de hiperactividad con deficit de atencion.
FR2962909A1 (fr) * 2010-07-21 2012-01-27 Oleg Iliich Epshtein Composition pharmaceutique d'association et son utilisation dans des procedes pour traiter les maladies ou affections associees avec une maladie ou affection respiratoire
JP2013537532A (ja) * 2010-08-06 2013-10-03 イリイチ・エプシテイン オレグ 感染性疾患を治療及び予防する組み合わせ医薬組成物及び方法
MX341921B (es) 2011-02-28 2016-09-07 Hoffmann La Roche Proteinas de union a antigeno.
CA2824824A1 (fr) 2011-02-28 2012-09-07 F. Hoffmann-La Roche Ag Proteines monovalentes de liaison a l'antigene
RU2013111962A (ru) 2013-03-18 2014-09-27 Олег Ильич Эпштейн Способ определения выраженности модифицирующей активности, ассоциированной с носителем
RU2013111961A (ru) 2013-03-18 2014-09-27 Олег Ильич Эпштейн Способ определения выраженности модифицирующей активности, ассоциированной с носителем
BR112016006929A2 (pt) 2013-10-11 2017-09-19 Hoffmann La Roche Anticorpo, ácido nucleico, vetor de expressão, célula hospedeira, métodos de preparação de anticorpo, de tratamento de pacientes e de geração de um anticorpo, composição farmacêutica e uso do anticorpo
WO2016087416A1 (fr) 2014-12-03 2016-06-09 F. Hoffmann-La Roche Ag Anticorps multispécifiques
CN107708718B (zh) * 2015-04-22 2022-01-11 西达-赛奈医疗中心 用于治疗2型糖尿病的肠内递送的苦味寡肽

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EP2036574A4 (fr) 2009-07-01
CA2654408A1 (fr) 2007-12-27
CA2654408C (fr) 2018-05-08
BRPI0712540A2 (pt) 2012-10-16
IL195755A (en) 2016-07-31
JP2009539827A (ja) 2009-11-19
EP2395021A1 (fr) 2011-12-14
IL246402A (en) 2017-12-31
US20160159916A1 (en) 2016-06-09
EA200802440A1 (ru) 2009-06-30
KR20090024241A (ko) 2009-03-06
US20110008452A1 (en) 2011-01-13
MX2008015621A (es) 2009-03-06
WO2007149010A1 (fr) 2007-12-27
JP5687425B2 (ja) 2015-03-18
US9308259B2 (en) 2016-04-12
IL195755A0 (en) 2011-08-01

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